MAUDE Adverse Event Report: COOK, INC. ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number AX1-1-26-108-ZT

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Death (1802)

Event Date 01/27/2015

Event Type  Death  

Event Description

This (b)(6) female pt in the spiral-z postmarket registry (b)(4) died as a result of acute hypoxic respiratory failure secondary to encephalopathy, sub-acute stroke in left cerebral hemisphere on (b)(6) 2015 (six days post-procedure).The pt was being treated for a 24 mm aortic aneurysm.The proximal neck had an irregular shape with partial plaque/thrombus.The left iliac artery had no tortuosity, severe occlusive disease and no calcification.The right iliac artery had mild tortuosity, moderate occlusive disease, and moderate calcification.The pt received a main body device and a right iliac leg.There was no difficulty deploying any of the devices.A molding balloon was used, but no details were provided regarding its use.There was no add'l devices used and no add'l procedures were performed.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, thrombus, or endoleaks.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4599482
• MDR Text Key: 15315195
• Report Number: 1820334-2015-00130
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Catalogue Number: AX1-1-26-108-ZT
• Device Lot Number: 4732815
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR